FDA.reportPublic FDA data

Phenazopyridine Hydrochloride

Product NDC
65162-682
11-digit product format
651620682
Labeler code
65162
Product ID
65162-682_9b599d15-523d-4e57-a844-800d995d35e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenazopyridine
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-02-01
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenazopyridine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094104, 1094107

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-682-10Phenazopyridine Hydrochloride100 in 1 BOTTLETABLET10013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-682PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) TABLET [AMNEAL PHARMACEUTICALS LLC]13Current NDC, Legacy NDC, 1 package rows20241031_b424b50f-990b-4018-a815-0311693cabb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094104phenazopyridine HCl 200 MG Oral TabletPSN6ac0f3ce-0cc2-403c-946d-13b285ae98aa100
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD6ac0f3ce-0cc2-403c-946d-13b285ae98aa100
1094104phenazopyridine HCl 200 MG Oral TabletPSNc1591037-62f4-469f-8bb2-a82e49dfbecf15
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDc1591037-62f4-469f-8bb2-a82e49dfbecf15
1094107phenazopyridine HCl 100 MG Oral TabletPSNb424b50f-990b-4018-a815-0311693cabb313
1094104phenazopyridine HCl 200 MG Oral TabletPSNb424b50f-990b-4018-a815-0311693cabb313
1094107phenazopyridine hydrochloride 100 MG Oral TabletSCDb424b50f-990b-4018-a815-0311693cabb313
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDb424b50f-990b-4018-a815-0311693cabb313
1094104phenazopyridine HCl 200 MG Oral TabletPSN82dc87bb-ba27-4b86-9bc9-18492975ac9f9
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD82dc87bb-ba27-4b86-9bc9-18492975ac9f9
1094104phenazopyridine HCl 200 MG Oral TabletPSNd8155f91-d650-4021-91ee-f3b6c1055a366
1094104phenazopyridine HCl 200 MG Oral TabletPSN900222e8-fc92-4d73-b3d5-1636e717bd656
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD900222e8-fc92-4d73-b3d5-1636e717bd656
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDd8155f91-d650-4021-91ee-f3b6c1055a366
1094104phenazopyridine HCl 200 MG Oral TabletPSNc0e5d32e-075f-4c76-8332-a06560001efe5
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDc0e5d32e-075f-4c76-8332-a06560001efe5
1094104phenazopyridine HCl 200 MG Oral TabletPSNc77eb633-9176-17ce-e053-2995a90a38803
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDc77eb633-9176-17ce-e053-2995a90a38803
1094104phenazopyridine HCl 200 MG Oral TabletPSNf2f3e29f-9553-f7c3-e053-2995a90aff362
1094104phenazopyridine HCl 200 MG Oral TabletPSNf40e173c-907a-648c-e053-2a95a90a9c872
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDf2f3e29f-9553-f7c3-e053-2995a90aff362
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDf40e173c-907a-648c-e053-2a95a90a9c872
1094104phenazopyridine HCl 200 MG Oral TabletPSN427b6ffb-3ff1-932f-e063-6394a90ae8b91
1094104phenazopyridine HCl 200 MG Oral TabletPSNe018e176-c4ec-42a2-9119-f1278cfa719a1
1094104phenazopyridine HCl 200 MG Oral TabletPSN3c9b98b0-72a5-44c5-a4de-7e950c5176c91
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD427b6ffb-3ff1-932f-e063-6394a90ae8b91
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCDe018e176-c4ec-42a2-9119-f1278cfa719a1
1094104phenazopyridine hydrochloride 200 MG Oral TabletSCD3c9b98b0-72a5-44c5-a4de-7e950c5176c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-682-1065162068210100 TABLET in 1 BOTTLE (65162-682-10) 100 tablet2011-02-010000-00-00NoNoCurrent